Diagnostics: Page 51
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Carolina Liquid gets FDA warning over sale of unauthorized reagents
FDA said Carolina Liquid distributed Class I and II IVD reagents without regulatory clearance. The warning is the latest in a series of letters issued this year to companies for distributing devices without premarket approval.
By Nick Paul Taylor • Nov. 20, 2019 -
Qiagen in talks with potential buyers amid weak results, restructuring
The molecular test maker confirmed Friday it has received several non-binding indications of interest, days after Bloomberg reported Thermo Fisher was eyeing a takeout of Qiagen.
By Susan Kelly • Nov. 18, 2019 -
BARDA backs Inflammatix test to improve antibiotic use
The $6 million contract will fund efforts to distinguish between bacterial and viral infections in a bid to limit overprescribing of antibiotics and the emergence of superbugs.
By Nick Paul Taylor • Nov. 15, 2019 -
Paige gets CE mark for prostate cancer detection technology
The software is designed to make it easier for pathologists to analyze biopsies for signs of cancer.
By Nick Paul Taylor • Nov. 13, 2019 -
FDA grants breakthrough status to AI-based gastric cancer diagnostic
The technology uses artificial intelligence to analyze endoscopy images for signs of gastric cancer.
By Nick Paul Taylor • Nov. 12, 2019 -
Exact Sciences closes Genomic Health deal, wins breakthrough tag for liver cancer blood test
The Cologuard maker said it intends to roll out the test for hepatocellular carcinoma in the second half of 2020.
By Maria Rachal • Nov. 8, 2019 -
Triple-digit liquid biopsy growth powers Guardant to beat-and-raise quarter
Guardant Health raised its full-year revenue guidance by around 10% after blasting past expectations.
By Nick Paul Taylor • Nov. 8, 2019 -
Hologic beats sales outlook on diagnostics, breast health
The women's health-focused company said it's planning to fuel further growth with more tuck-in acquisitions. But analysts gave a muted response to the results and shares were down 5% Thursday morning.
By Nick Paul Taylor • Nov. 7, 2019 -
FDA authorizes 1st NGS test for HIV drug resistance mutation
By detecting 342 HIV drug resistance mutations in blood samples, the next-generation sequencing test gives physicians a different way to assess resistance and tailor treatments to patients, the agency said.
By Nick Paul Taylor • Nov. 6, 2019 -
Myriad shares plunge 40% after missing targets, slashing outlook
Investors punished the genetic test maker after it reported double-digit drops in sales of its key cancer and depression products.
By Nick Paul Taylor • Nov. 5, 2019 -
Sharp drop in Chinese sales drags Qiagen down in Q3
Sales in China fell 24% in the quarter, which Qiagen attributed to a slowdown in distributor orders and the end of its next generation sequencing joint venture.
By Nick Paul Taylor • Oct. 31, 2019 -
Exact Sciences Q3 revenue jumps 85% but Cologuard orders disappoint
Shares in the non-invasive colon cancer test manufacturer fell approximately 6% Wednesday. Exact plans to focus on increasing payer coverage of Cologuard and communicating its label expansion to doctors.
By David Lim • Oct. 30, 2019 -
CMS proposes lifting restrictions on NGS cancer testing
The agency revised its proposed national coverage determination after receiving more than 80 comments, with potential plans to extend coverage of next generation sequencing tests to earlier-stage and hereditary cancers.
By Nick Paul Taylor • Oct. 30, 2019 -
UK regulator mulls blocking Illumina's $1.2B PacBio takeover
The watchdog said the union "would result in a significant reduction of competition," leading some analysts to predict the deal won't go through.
By Nick Paul Taylor • Oct. 25, 2019 -
Rivals LabCorp and Quest post improved outlooks despite PAMA woes
Quest's volume gains exceeded those of rival LabCorp, but came at the expense of its revenues per requisition, which fell 1.2% in the third quarter.
By Nick Paul Taylor • Oct. 24, 2019 -
Device to ID obstructions in post-PCI patients wins breakthrough status
Swiss startup CorFlow Therapeutics created the device to both assess and treat microvascular obstruction in patients after percutaneous coronary intervention.
By Nick Paul Taylor • Oct. 24, 2019 -
J&J reports rising success rate in robotic surgery clinical trial
The study is assessing diagnostic abilities of the Monarch robotic surgery platform, which Johnson & Johnson gained in the $3.4 billion acquisition of Auris Health.
By Nick Paul Taylor • Oct. 24, 2019 -
Medtronic rolls out AI-assisted colonoscopy system in Europe
The medtech giant expects to introduce the system in the U.S. market in the second half of 2020, a company spokesperson told MedTech Dive.
By Susan Kelly • Oct. 21, 2019 -
Abbott 'working through a handful of items' with FDA on FreeStyle Libre 2
Third-quarter revenue for the medtech came in at $8.08 billion, slightly below Wall Street expectations, but executives praised the growth of key products FreeStyle Libre, MitraClip and Alinity on its earnings call.
By David Lim • Oct. 16, 2019 -
Ancestry takes on 23andMe, rolls out genetic health test services
The company will be working with Quest Diagnostics and Illumina to sell the laboratory developed tests. It does not currently have a relationship with LabCorp, according to an executive.
By David Lim • Oct. 15, 2019 -
Medical software makers get new guidance on MDR, IVDR
The European Commission's Medical Device Coordination Group aims to clarify which software will be subject to the new regulations, and how those products should be classified and placed on the market.
By Dana Elfin • Oct. 14, 2019 -
FDA clears first rapid Ebola virus diagnostic
Risk of flare up remains, but the United Nations called the outbreak responsible for killing 2,100 people over 14 months in the Democratic Republic of the Congo "significantly contained."
By Nick Paul Taylor • Oct. 11, 2019 -
CDS software, labels for staplers and breast implants among FDA 2020 guidance priorities
The annual publication comes days after the White House issued an executive order aimed at limiting agency use of the documents.
By David Lim • Oct. 11, 2019 -
Experimental cancer IVD trial guidance finalized
AdvaMed won many many of the changes it sought during the comment period, including ones related to communication with the FDA.
By Nick Paul Taylor • Oct. 10, 2019 -
Fresenius to pay $5.2M to settle Medicare overbilling allegations
DOJ alleged the company overbilled Medicare for more than seven years by ordering hepatitis B tests for patients it knew to be immune to the virus.
By Nick Paul Taylor • Oct. 10, 2019
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